Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of idp-118 lotion in the treatment of plaque psoriasis

Conditions: Psoriasis

Summary: safety and efficacy of idp-118 lotion in the treatment of plaque psoriasis

a phase 2, multicenter, double-blinded, randomized, vehicle-controlled study to compare the safety and efficacy of idp-118 lotion with tazorac (tazarotene) cream, 0.05% in the treatment of plaque psoriasis

Eligibility criteria:
key inclusion criteria: * male or female, of any race, at least 18 years of age (inclusive). * freely provides both verbal and written informed consent. * has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (bsa) of at least 3%, but no more than 12%. the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * has a clinical diagnosis of psoriasis at the baseline visit with an (iga) investigator global assessment score of 3 or 4. (the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment, if psoriasis is present.) key exclusion criteria: * has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. * presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
a study to assess the safety of single doses of gsk189075 in subjects with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this research study is to look at concentrations of gsk189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. the clinical effects of the drug in combination with insulin on the body will also be studied. the results will help determine doses of gsk189075 can be studied in the future in the type i diabetes mellitus population.


Eligibility criteria:
inclusion criteria: * adult male/female, 18 to 55 years old * diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump * willing and able to follow all study-related instructions provided by the site staff. * willing to provide signed informed consent. exclusion criteria: * pregnant or a nursing female. * have a past or current disease such as heart, liver, kidney, blood, brain, or other disease. * have hiv or hepatitis, or have alcohol or drugs in your system at the screening visit. * have a history of alcohol abuse or have an eating disorder * have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken.

Keywords: type 1 diabetes mellitus, pharmacokinetics, pharmacodynamics adult male and females,
a safety study of the pan-immunotherapy in patients with unresectable/metastatic solid tumors or lymphomas

Conditions: Solid Tumor; Lymphoma

Summary: identification of t cell inhibitory signals, including pd-1/pd-l1, has prompted the development of a new class of cancer immunotherapy that could restore an adequate immunosurveillance against the neoplasm and enhance t-cell-mediated anticancer immune responses. however, elimination of cancer by t cells is only one step in the cancer-immunity cycle, which enable providing several therapeutic targets and tailoring of combinations of immune therapies. manganese has been confirmed to activate antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies. this study is a first-in-man, phase i, 3 + 3 dose escalation study of a combined regimen of manganese and anti-pd-1 antibody with or without chemotherapies in subjects with unresectable/ metastatic solid tumors or lymphomas. this study is designed to assess the safety, tolerability, pharmacokinetic profile (pk profile), mode of delivery and recommended phase 2 dose (rp2d) of this regimen.


Eligibility criteria:
inclusion criteria: 1. subjects must have histologically proven unresectable/ metastatic solid tumors or lymphomas. 2. ≥ 18 years old. 3. life expectancy of at least 6 months. 4. eastern cooperative oncology group performance status 0-2. 5. subjects must have at least one measurable lesion ≥ 1 cm as defined by response criteria. 6. subjects must have received at least two frontline therapies, except for patients initially diagnosed with local advanced or metastatic pancreatic cancer or cholangiocarcinoma. 7. subjects must be off prior therapy for at least 4 weeks prior to day 1. subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. subjects with anti-pd-1 antibody are eligible which must be resistance. 8. adequate organ function. 9. participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug. exclusion criteria: 1. subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications. 2. serious uncontrolled medical disorders or active infections, pulmonary infection especially. 3. t cell lymphomas or leukemia. 4. prior organ allograft. 5. women who are pregnant or breastfeeding. 6. women with a positive pregnancy test on enrollment or prior to investigational product administration. 7. subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Keywords: anti-pd-1 antibody manganese unresectable metastatic
ct-011 mab in dlbcl patients following asct

Conditions: Lymphoma, Large Cell, Diffuse; Lymphoma, Mixed Cell, Diffuse; Primary Mediastinal Large B-Cell Lymphoma

Summary: autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-b cell lymphoma (dlbcl) following relapse of the disease. although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. the purpose of this study is to test the safety and effectiveness of the monoclonal antibody, ct-011, in patients with dlbcl who have received autologous peripheral blood stem cell transplantation. all final eligible patients will receive an iv infusion of ct-011 on day 1 (30 to 90 days post autologous pbsct). treatment will be repeated every 42 days for a total of three courses with treatment visits on days 1, 43, and 85. follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous pbsct. approximately 70 patients will participate in this study.


Eligibility criteria:
inclusion criteria: 1. patient's age is 18 years or older, both genders. 2. confirmed diffuse large b-cell lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with b-cell lineage. 3. the lymphoma is chemosensitive. 4. the lymphoma did not progress since pre-transplant chemotherapy. 5. ecog performance status 0-1. exclusion criteria: 1. serious other illness. 2. active autoimmune disease. 3. type 1 diabetes. 4. known immune deficiency. 5. clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma. 6. active bacterial, fungal, or viral infection. 7. positive hiv, hepatitis b surface antigen plus viremia, or hepatitis c antibody plus viremia. 8. pregnant or nursing (positive pregnancy test). 9. other concurrent clinical study or investigational therapy.

Keywords: lymphoma, large b-cell, diffuse transformed follicular lymphoma stem cell transplantation relapsed refractory
insulin resistance in primary hyperparathyroidism

Conditions: Hyperparathyroidism; Diabetes; Hypercalcemia

Summary: the aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (phpt) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of phpt.

to be conducted at the karolinska university hospital, stockholm. patients with fb-glucos \>6.1 and hba1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (ptx) within three months or not. the groups will be examined 4 ±4 weeks before and 12±2 weeks after ptx, similar for the control group. the number of participants will be estimated by power calculations based on a pilot study including 20 patients. the test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.

Eligibility criteria:
inclusion criteria: * primary hyperparathyroidism and fb-glukos\>6,1 and/or hba1c \> 39 mmol/mol exclusion criteria: * treatment with insulin, sulfonylurea or metformin

Keywords: hyperparathyroidism insulin resistance
trial of doxycycline to reduce sputum mmp-9 activity in adult cystic fibrosis (cf) patients

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to examine the role of a well-known and well-tolerated antibiotic, doxycycline, in the treatment of cystic fibrosis patients who are hospitalized. this antibiotic does not effectively treat the bacteria in airways of cystic fibrosis patients, but may reduce the activity of inflammatory molecules in the disease.

one molecule that is inhibited by doxycycline is matrix metalloprotease-9, which is emerging as an important mediator of lung inflammation and damage in cystic fibrosis. we hypothesize that the addition of treatment with doxycycline in cf inpatients will reduce mmp-9 activity and inflammatory markers in the sputum of cystic fibrosis patients compared to cf patients not treated with doxycycline.

Eligibility criteria:
inclusion criteria: * cystic fibrosis * hospitalization for pulmonary exacerbation exclusion criteria: * significant gi illness * participation in another investigational protocol * allergies to doxycycline * sputum culture only positive for staphylococcus aureus, * pregnant or nursing * unwilling to use effective birth control * elevated lft's greater than 3x the upper limit of normal * creatinine greater than 1.5x the upper limit of normal * lung transplantation * substance abuse within 30 days of screening

Keywords: cystic fibrosis
prospective project to identify biomarkers of morbidity and mortality in cardiovascular interventional patients

Conditions: Atrial Fibrillation; Coronary Artery Disease; Aortic Valve Stenosis; Aortic Valve Disease; Mitral Valve Disease; Cardiac Arrythmias; Cardiac Tumor; Cardiac Surgery

Summary: the objective of carebank study is to establish definitive relationships with human cardiac samples and clinical phenotypes in patients undergoing cardiac procedures. specifically, the investigators aim at comparing atrial phenotypes from atrial fibrillation patients and controls. the work consists of three broad categories: a) role of atrial cardiomyopathy in atrial fibrillation; b) genetic defects predisposing to atrial fibrillation; and c) the role of inflammation in atrial fibrillation.

the investigators aim to a) compare atrial cardiomyopathy findings from the tissue samples to clinical phenotype and adverse events b) study the association of genetic defects predisposing to atrial fibrillation with atrial cardiomyopathy findings in the tissue samples c) assess the role of inflammation in atrial fibrillation by comparing circulating cytokine profiles, purinergic signaling and atrial cardiomyopathy findings in tissue samples.

Eligibility criteria:
inclusion criteria: * any open-heart cardiac surgery * written informed consent * all-comers design exclusion criteria: * no informed consent

Keywords: atrial fibrillation aortic stenosis coronary artery disease cardiac surgery atrial appendage
national survey on coronary patients and heart failure performed in 2 patient groups

Conditions: Coronary Patients; Heart Failure

Summary: the purpose of this observational study is to compare frequency of attainment control goals through the more represented cardiovascular factor risk, dyslipidemia, among coronary patients with or without heart failure in cardiology consulting.


Eligibility criteria:
inclusion criteria: * patient with coronary disease diagnosed since at least 1 year * echocardiography done less than 1 year ago * patient with or without documented heart failure exclusion criteria: * none

Keywords: coronary patients heart failure dyslipidemia
support through remote observation and nutrition guidance (strong) program for pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: the purpose of the study is to assess the feasibility and participant satisfaction with the support through remote observation and nutrition guidance (strong) program. the program provides enhanced dietician access and nutrition support for participants living with pancreatic cancer who are receiving chemotherapy.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosed metastatic or newly recurrent pancreatic cancer or locally advanced pancreatic cancer * receiving chemotherapy under the guidance of moffitt * able to speak and read english * able to provide informed consent exclusion criteria: * documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g., psychosis, active substance abuse). * undergoing concurrent treatment for a second primary gi cancer * ecog status of 2 or greater * use of parenteral or enteral nutrition * presence of malignant ascites
whole grains, gastric emptying and glycemic response

Conditions: Obesity; Diabetes Mellitus, Type 2; Appetitive Behavior

Summary: whole grains have been associated with controlled glycemic response and increased satiety compared to refined grains. however, the properties of whole grains which are responsible for these purported improved health outcomes are still unclear. the current study investigated the extent of whole grains' low glycemic property when food properties are controlled, and how this relates to gastric emptying rate and glycemic response.

it is generally assumed that whole grain foods confer a health benefit in regards to moderated glycemia and increased satiety compared to foods made from refined grains. however, the extent of whole grains' low glycemic property may be limited by certain factors. for example, physical properties such as viscosity or particle size and differing starch digestion rates of whole grain foods may strongly influence glycemic response and gastric emptying rate. in this study, whole and refined grain wheat porridges were prepared from materials originating from the same milling source, with matched pairs for viscosity, starch and dietary fiber contents, and particle size. subjects consumed wheat porridges containing 13c-labeled octanoic acid for assessment of gastric emptying rate, and they wore a continuous glucose monitor for measuring postprandial glucose levels. the purpose of this research was to test the hypothesis that the purported moderated glycemic response and slow gastric emptying rate are dependent on how these foods are processed. this work highlights the need to consider specific properties of whole grain foods for desired health outcomes in order to optimize the design of whole grain-based foods.

Eligibility criteria:
inclusion criteria: * aged between 18-50 years old * healthy, normal bmi (18.5 kg/m² \<bmi \< 25 kg/m²) * be free of any gastrointestinal diseases, diabetes, cardiovascular diseases * be free of any wheat allergies and gluten intolerances or sensitivities * not be pregnant or nursing exclusion criteria: * no medical problems * no medication * pregnant or nursing
effects of amitriptyline for the treatment of pain on driving performance and cognition.

Conditions: Chronic Neuropathic Pain

Summary: the acute and subchronic effects of amitriptyline were compared to placebo in a double-blind crossover randomized study on driving ability and driving-related skills in chronic neuropathic pain patients.it was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

the present study was designed to determine the effects of nocturnally administered 25 mg amitriptyline, compared to placebo, after single (day 1, acute effects) and repeated (day 15, subchronic effects) administration on driving performance in neuropathic pain patients. in addition to the on-the-road driving test, laboratory tests measuring driving-related skills were administered. moreover, effects of amitriptlyine on an attentional capacity task were tested using event-related potentials (erps). it was hypothesized that nocturnally administered 25 mg amitriptyline might affect driving performance negatively after acute, but not after subchronic treatment.

Eligibility criteria:
inclusion criteria: * age, amitriptyline responder, adequately treated with amitriptyline in studied dose before study participation, pain intensity score (vas) of at least 4 cm on a 10 cm scale, driving licence, driving experience, speak fluently dutch, normal vision, right-handed exclusion criteria: * psychological or physical disorder other than pain(-related), other psychotropic medication use, excessive drinking or smoking, alcohol- or drug dependence, illigal drug use

Keywords: neuropathic pain erp driving attention amitriptyline
levobetaxolol hydrochloride eye drops for treatment of primary open-angle glaucoma or ocular hypertension

Conditions: Primary Open-angle Glaucoma; Ocular Hypertension

Summary: to evaluate the safety and efficacy of levobetaxolol in chinese patients with glaucoma.

to evaluate the safety and efficacy of levobetaxolol in chinese patients with primary open-angle glaucoma or ocular hypertension.

Eligibility criteria:
inclusion criteria: * agreed to participate in this clinical trial and informed consent; * aged 18 to 70 years of age, male or female; * in line with primary open-angle glaucoma diagnostic criteria, iop ≥18mmhg; * or in compliance with ocular hypertension diagnostic criteria, intraocular pressure\> 21mmhg exclusion criteria: * known or suspected to be allergic to investigational drugs and materials * has been diagnosed with angle-closure glaucoma, absolute glaucoma, glaucoma ciliary body syndrome, secondary glaucoma. * merge various retinal lesions, such as retinal detachment, retinal vein occlusion, retinitis pigmentosa. * merge associated with eye infections or cornea, iris, lens obvious lesions, or one-eyed patients. * during the trial who must wear contact lenses, or nearly three months experts any eye surgery or laser treatment. * need systemic β-blocker therapy during the study. * with severe kidney disease, or abnormal liver function tests (alt, ast≥ 1.5 times the upper limit of normal, scr\> upper limit of normal). * merge sinus bradycardia, over ⅰ degree atrioventricular block, cardiogenic shock, heart failure, symptomatic hypotension or other serious heart, lung diseases (such as bronchial asthma or a history of bronchial asthma, chronic obstructive lung disease, bronchospasm, respiratory failure, etc.). * merge hyperthyroidism, myasthenia gravis, diabetes, advanced cancer, blood and hematopoietic system diseases, or other serious or progressive disease systems. * associated with neurological and psychiatric disorders * suspect or indeed alcohol, drug abuse history. * pregnancy, lactation or recent fertility planner. * the researchers believe other circumstances were not involved in this trial. * participate in other clinical trials within three months.

Keywords: safety efficacy levobetaxolol eye drops chinese patients
the link between human cytomegalovirus (hcmv) and hypertension

Conditions: HCMV Infection; Hypertension

Summary: it has been reported that mouse cytomegalovirus infection alone can elevate the blood pressure in mice. since hcmv has uniquely evolved with its human host, with little genetic similarity to the animal cmv counterparts, and it only replicates in human, an epidemiological study is required to define the relevance of hcmv infection and expression of hcmv-mirna-ul112 to the pathogenesis of essential hypertension. the investigators found that hcmv-mir-ul112, a human cytomegalovirus (hcmv)-encoded mirna, was highly expressed in the hypertensive patients. among the top mirna target predictions, the investigators demonstrate that irf-1 is a direct target gene of hcmv-mir-ul112, along with micb that has been previously reported. both irf-1 and micb play critical roles in immuno/inflammatory and anti-infection response. thus, the investigators speculated that irf-1 and micb repression by hcmv-mir-ul112 could be considered a unifying mechanism that evades the host response at several levels: antiviral, inflammatory, and immune. in addition, there is an increasing evidence that irf-1 may be important in apoptosis, angiogenesis, neointima formation and the pathogenesis of vascular diseases. irf-1 can up-regulate angiotensin ii type 2 receptor (agtr2) that exerts antiproliferative and proapoptotic actions and affects regulation of blood pressure. it has been reported that the targeted disruption of the mouse agtr2 gene resulted in a significant increase in blood pressure and increased sensitivity to angiotensin ii. the nitric oxide synthase expression and no synthesis in macrophages and distinct cardiomyocytes are induced and controlled by irf-1 in response to inflammation, important steps in vascular biology that may improve endothelial function and inhibit smooth muscle cell migration, and a key pathophysiological event in hypertension. collectively, these reports support a strong relationship between irf-1 regulation and hypertension, indicating a potential role of hcmv-mir-ul112 and hcmv infection in the pathogenesis of hypertension.thus, the investigators want to investigate the potential link between hcmv infection and essential hypertension.


Eligibility criteria:
inclusion criteria: * patients with essential hypertension are assessed for potential secondary causes, for the severity of hypertension, other risk factors and for end-organ damage * aged between 30 to 60 years * untreated (whole day average \> 140/90 mmhg) or treated hypertension whole-day average \< 140/85), as determined by 24-hour blood pressure monitoring. exclusion criteria: * cancer * diabetes * smoking * renal failure * stroke * peripheral artery disease

Keywords: hcmv infection hypertension the potential link between hcmv infection and essential hypertension